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FDA 510(k)

OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK

K-Number: K951811 · 1995-05-31

ApplicantOsteotech, Inc.
Decision Date1995-05-31
Product CodeLRP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK is the device name listed in this FDA 510(k) record. The listed applicant is Osteotech, Inc.. It received FDA 510(k) clearance on 1995-05-31 under 510(k) number K951811. The device is classified under product code LRP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK?

OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK is a medical device that received FDA 510(k) clearance on 1995-05-31. The listed applicant is Osteotech, Inc.. The 510(k) number is K951811.

When did OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK receive FDA 510(k) clearance?

OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK received FDA 510(k) clearance on 1995-05-31, under 510(k) number K951811.

Who is the listed applicant for OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK?

The FDA 510(k) record lists Osteotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK?

The FDA product code for OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK is LRP.

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Other records listing Osteotech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K082615GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICESK081227PLEXUR MK080511PLEXUR-PK073405PLEXUR MK061982PLEXUR PK051188GRAFTON DBM

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Related Devices (Code: LRP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K963723LACERATION TRAYGrand Medical ProductsK940239EYE TRAYCush Medical ProductsK935621CUSTOM ENT PACKSAssociated MedicalK940646ORTHOPEDIC TRAY PRODUCT LINECushinduK940444GENERAL SURGERY TRAYCush Medical ProductsK922126HOSPITAL KIT ENT 1125Savoy Medical Supply Co., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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