510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Acromed Corp.

Cleveland, OH, US

Acromed Corp. appears in FDA device records in Cleveland, OH. FDA records list 41 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
41
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 41 510(k) clearances for Acromed Corp. between 1984 and 1998. The busiest year on record is 1997, with 8. The most recent is 1998, with 6.

Clearances by year, as a table
510(k) clearance decisions for Acromed Corp., by decision year
YearClearances
19841
19882
19893
19901
19915
19922
19932
19956
19965
19978
19986
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K980485ISOLA SPINAL SYSTEMMNISubstantially Equivalent
K981714TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEMMNHSubstantially Equivalent
K981113PEDIATRIC PRCMNHSubstantially Equivalent
K981274ACROMED TIMX PLATE BASED LOW BACK SYSTEMMNHSubstantially Equivalent
K980228UNIVERSITY PLATE ANTERIOR SYSTEMKWQSubstantially Equivalent for Some Indications
K974757KANEDA ANTERIOR SCOLIOSIS SYSTEM KASSKWQSubstantially Equivalent for Some Indications
K972718M-2 ANTERIOR PLATE SYSTEMKWQSubstantially Equivalent for Some Indications
K971248KANEDA SR ANTERIOR SPINAL SYSTEMKWQSubstantially Equivalent for Some Indications
K970955ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEMKWQSubstantially Equivalent for Some Indications
K970950EASY RODMNHSubstantially Equivalent
K965102ACROMED PEDICLE SCREWMNHSubstantially Equivalent
K970462ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEMKWQSubstantially Equivalent
K965046ISOLA TWISTER CONNECTORMNHSubstantially Equivalent for Some Indications
K953978ANTERIOR DYNAMIZED SYSTEMKWQSubstantially Equivalent
K964007ACROMED CABLE/WIRE PEDICLE SCREWMNHSubstantially Equivalent for Some Indications
K962984ISOLA PEDIATRIC COMPONENTSKWPSubstantially Equivalent for Some Indications
K963639ACROMED PEDICLE SCREWKWPSubstantially Equivalent for Some Indications
K962645ISOLA TWISTER CONNECTORMNHSubstantially Equivalent
K952236ISOLA SYSTEMMNHSubstantially Equivalent for Some Indications
K951657VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S)MNHSubstantially Equivalent for Some Indications
K951116ACROMED PEDICLE SCREWMNHSubstantially Equivalent for Some Indications
K944737ISOLA SPINE SYSTEMMNHSubstantially Equivalent
K944756ISOLA OPEN AND CLOSED SCREWSMNHSubstantially Equivalent for Some Indications
K944736VSP (VARIABLE SCREW PLACEMENT)MNHSubstantially Equivalent
K943819ISOLA ANTERIOR SYSTEMKWQSubstantially Equivalent for Some Indications
K923703KANEDA ANTERIOR SPINAL MULTISEGMENTAL FIXATION DEVKWQSubstantially Equivalent for Some Indications
K922504ISOLA(R) TANDEM CONNECTORKWPSubstantially Equivalent for Some Indications
K921090ISOLA(R) TRANSVERSE ROD DUAL CONNECTORKWPSubstantially Equivalent
K920392ISOLA SPINE SYSTEM: PLATE-ROD COMBINATIONKWPSubstantially Equivalent
K904446CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.)KWQSubstantially Equivalent
K911528ISOLA(TM) SPINE SYSTEM - ILIAC SCREWKWPSubstantially Equivalent for Some Indications
K911394ISOLA(TM) SPINE SYSTEM--EYE RODKWPSubstantially Equivalent
K905826ISOLA SLOTTED CONNECT/ANGLED SLOTTED CONNECTORKWPSubstantially Equivalent
K905184ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOKKWPSubstantially Equivalent for Some Indications
K903376ACROMED SACRAL SCREWKWPSubstantially Equivalent for Some Indications
K895441ACROMED BUTTON SPINAL WIREKWPSubstantially Equivalent
K895439ACROMED BEADED SUBLAMINAR WIREKWPSubstantially Equivalent
K895413ACROMED DOUBLE SUBLAMINAR WIREKWPSubstantially Equivalent
K873826ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATIONKWQSubstantially Equivalent
K874882ACROMED CROSS ROD CONNECTORKWPSubstantially Equivalent
K842845BONE MILL BONE GRINDERSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Acromed Corp. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Acromed Corp.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

Data as of , FDA export datePage updated Source: openFDA, public domain